COIR FAQ

Conflict of Interest in Research Disclosure FAQ

Q: What is the purpose of the WVU Conflict of Interest in Research disclosure
requirements?

A: Disclosure is required whenever there is an actual conflict of interest
so that a management strategy can be developed to assure that the actual conflict
does not interfere with the employee's performance of his/her University responsibilities.
Disclosure may also be required when there is an appearance of a conflict even
though, in fact, there is no actual conflict. In this case, disclosure can be beneficial
to both the University and the employee in order to protect them against unfounded
claims of impropriety. Disclosure does not necessarily mean that the employee may
not engage in the disclosed activity.

Q: I am an employee with a consulting business and want to hire a graduate
student I am advising to do some research for this outside activity. Is this ok?

A: This represents a conflict of interest that probably can be managed.
It is important that both you and the student understand that engaging (or even
a decision to not engage) in this outside activity can in no way influence the
student's academic relationship with the advisor and the University. In order to
insure this, any arrangement should be disclosed and reviewed periodically for
a continuing relationship.

Q: I am an employee with a consulting business and wish to use University
facilities (including personnel) to test some samples for a company for which I
am consulting. How can I do this?

A: This represents a conflict of interest that may be manageable through
a contract with the University. You may submit a proposal through the Office of
Sponsored Programs and use the appropriate forms to disclose your relationship
to the consulting business. In this case it appears that there are no intellectual
property issues and so the primary issue is deciding on a fair value for the services
to be performed. This may be suggested by the unit's chair, and the Research Office
as part of the disclosure review process.

Q: I am an employee with a small research business and we wish to submit
a "small business innovative research (SBIR)" project to the federal government
(the University is not eligible to apply directly to these programs) in which we
would subcontract the experimental work to the University. How can this be done?

A: This may be possible, as in the previous question, with the addition
of the need to negotiate an intellectual property agreement with the University.

Q: I am an employee who, with my spouse and children, owns ten percent
interest in a small biotechnology company. The combined value of the stock we hold
in this company is $25,000. I am writing a research proposal that I plan to submit
to the National Institutes of Health to support a project that is related to the
business interests of the company. Can I do this?

A: You may be able to do so. To comply with University Guidelines and
National Institutes of Health rules, you will need to disclose your involvement
in the company by acknowledging the presence of a potential conflict of interest
by completing the Certifications, Disclosures, and Assurances section of the proposal
routing form at the time you are submitting your proposal. Your involvement in
the company and project will be reviewed at that time. If you receive funding from
NIH, agency rules and University Guidelines may require further review and restrictions
or conditions may be imposed to manage, reduce, or eliminate the possibility that
your research project could be influenced by your business interests. The NIH rule
requires that the University certify that such issues have been resolved before
you start spending any funds for your research project. Any intellectual property
resulting from such research will, as usual, need to be processed through the Office
of Technology Transfer.

Q: I have a consulting arrangement with Pharmaceutical Company X, which
markets drugs related to my medical specialty. I do not have an active research
program and do not receive any research funding from Company X or any of its competitors.
Is this a conflict of interest?

A: It could be, especially if you prescribe Company X's products to your
patients, evaluate the results and report those results to Company X.

Q: I am a participant in a national protocol developed by Pharmaceutical
Company Q. They provide the medication in a blinded protocol and patients are selected
at random for the medication. I collect the designated patient data and forward
it to the company and they reimburse me for each completed patient. This includes
a physician's fee, which I receive through my PPP. Do I have a conflict of interest?

A: If you administer the medication blinded and to random patients and
forward the patient data to the company, there is no conflict. However if the study
is not blinded and you select the patients, gather the patient data and forward
the information to the company, there could be a conflict in that a bias could
be used in selecting the patients, especially if you provide any evaluation of
the patient data.

Q: I have a business arrangement (i.e., a consulting or executive position)
with a biotech company and they pay me to review research data and provide them
with my evaluation. They do not support any of my research. I do have support from
other sources for my research, which is related to the area of the biotech. Is
this a conflict?

A: Yes, this is a potential conflict of interest as it may bias your research
evaluations or otherwise affect your research results.

Q: My spouse is a member of the Board of Directors of a company that competes
with a company for which I do research. Is there a conflict in this situation?

A: Yes, this situation represents a potential conflict of interest. Due
to relationships within families, there could exist the potential of a bias in
the research you conduct.

Q: I am doing research funded by a pharmaceutical company in which I have
not purchased stock. My father-in-law recently died and left in his estate to my
wife stock in this company. Am I in violation of the WVU Conflict of Interest in
Research Guidelines?

A: If the value of the stock is at least $5,000 there is a conflict of
interest that must be reported. It is for circumstances such as these that NSF
and NIH require an annual evaluation since conflicts may not be present at the
beginning of funded research but may surface sometime during the research period.

Example Situations

Creating a Possible Conflict of Interest in Research

The examples are by no means exhaustive, and are provided only as samples of commonly
encountered situations.

Entering into consulting agreements that purport to transfer to a private entity
intellectual property that belongs to the University. (See the University's
Policy on Patents and Copyrights for further detail.)

Undertaking basic or clinical research when the investigator or the investigator’s
immediate family has financial, managerial, or ownership interest in the sponsoring
company or in the company producing the drug/device under evaluation

Accepting gratuities or special favors from research sponsors

Entering into a consultantship arrangement with an organization or individual having
an economic interest in related research

Using students or employees of the University to perform services for a company in
which an employee has an ownership interest or from which he/she receives any
type of remuneration

Unreimbursed or unauthorized use of University resources, such as equipment, supplies,
and facilities, for personal research or to support the research activities
of an independent entity in which an investigator holds a financial or other
interest

Unauthorized use of privileged information acquired in connection with one’s professional
responsibilities

Accepting support for basic or clinical research under terms and conditions that
results be held confidential, unpublished, or significantly delayed in publication

Providing privileged access to information, developed with University resources or
supported by independent sponsors, to an entity in which the employee has a
financial interest

Purchasing equipment, instruments or supplies for research or teaching from a firm
in which the employee has a financial or other interest

Consulting to a federal agency when one is conducting federally-sponsored research
(the federal conflict of interest statutes 18 U.S.C. § 202-209 should be consulted)

Conflicts of Interest, Defined by Policy and Law

Detailed disclosure, review, and approval are also required prior to submission of
the research proposal to the research sponsor(s) when the Investigator will be
engaged in any of the following: (not an exclusive list). Depending on the facts,
management plans may be possible for some after disclosure and review.

A proposal to a research sponsor, including a start-up company

From which the Investigator receives or anticipates receiving compensation in excess
of $5,000 during a calendar year; or

In which an Investigator has an equity or profits interest greater than five percent
(5%) of all equity or profits interests or worth more than $5,000; or

From which an Investigator is entitled to receive royalties under a license or assignment
of the University’s intellectual property rights to such proposed sponsor.

A proposal to evaluate technology that is owned by a business

From which the Investigator receives or anticipates receiving compensation in excess
of $5,000 during a calendar year; or

In which an Investigator has an equity or profits interest greater than five percent
(5%) or worth more than $5,000.

A proposal to a research sponsor involving a waiver or preferential reduction of
University direct or indirect costs to benefit the sponsor

From which the Investigator receives or anticipates receiving compensation in excess
of $5,000 during a calendar year; or

In which an Investigator has an equity interest greater than five percent (5%) or
worth more than $5,000.

A proposal involving the purchase of equipment or other materials from a vendor or
supplier

From which the Investigator receives or anticipates receiving compensation in excess
of $5,000 during a calendar year; or

In which an Investigator has an equity or profits interest greater than five percent
(5%) or worth more than $5,000.

Doing research involving a technology that has been licensed or offered under an
option to the sponsor or other commercial entity under an arrangement that will
result in the Investigator(s) receiving royalties or other compensation from
the commercial exploitation of the technology.

Consulting for a fee with the research sponsor.

Speaking for a fee with the research sponsor.

Serving on a scientific advisory board of the research sponsor for a fee. The conflicted
investigator would be required to recuse himself or herself from matters involving
the conflict.

Receiving honoraria from the research sponsor.

Receiving nominal gifts and gratuities from a research sponsor

Receiving research support from or doing research for a sponsor in which the Investigator
holds an equity or profits interest, including stock options or expectations
of receiving equity interests, in excess of five percent (5 %) or $5,000.

Receiving research support from or doing research for a sponsor in which an Investigator’s
immediate supervisor, co-investigator on that project, or any laboratory staff
or students who are directly supervised by that Investigator and who would be
engaged in the proposed project or their immediate family individually or collectively
hold equity in excess of five percent (5 %) or $5,000.

Receiving external research support involving non-investigators employees or students
to whom the circumstances described above apply.

Serving on Board of Directors of the sponsor.

Serving as an officer of the sponsor.

Using students, fellows, and staff to perform services for a company in which the
investigator has a financial interest, imposing confidentiality restrictions
on them, or allowing the conflict to interfere with their academic freedom or
ability to publish data.

A University investigator shall not ordinarily participate in any clinical trial
of a therapeutic strategy or product if the investigator (or immediate family
member) is in a position to receive royalties or other compensation as a result
of the commercial success of such strategy or product or has an equity interest
(except in publicly-held entities on terms generally available to the public)
in the producer of that product. An exception may be made upon a written finding
by the COIR Director that the investigator is uniquely qualified to perform the
research and no other person who is unbiased can be substituted because of unique
technology or other applications. In such a case, the investigator may be allowed
to conduct certain aspects of the research under a strict management plan. For
example, if the technology is such that the investigator is the only individual
who can perform it, the performance might be allowed, but the investigator could
not recruit human subjects, administer the informed consent, analyze the data
(except in an appropriately blinded study), etc. By definition, a multisite clinical
trial would not qualify for the exception.